1) The Associate Director of the Clinical Research Support Office will assist with the day-to-day management of the regulatory services provided by the CRSO.
2) Maintain an overall awareness of clinical research activities across the Department of Medicine, with particular emphasis on faculty who seek direct support from the CRSO.
3) Initiate and maintain continuous improvement efforts related to regulatory compliance.
4) Develop and maintain standard operating procedures related to regulatory compliance.
5) Assist Research Managers with training needs related to regulatory compliance.
6) Meet with new faculty for CRSO/regulatory orientation.
7) Provide FDA audit support across Department of Medicine.
8) Provide investigator-sponsor FDA IND/IDE development and study planning.
9) Participate in research protocol development and provide direct IRB (and related) submission and maintenance as needed.
10) Facilitate partnership with outside study sponsors (industry, collaborating universities, etc), clinical research organizations (croâ™s), and central IRBs.
11) Participate in continuous staff training, including protocol development and study planning with junior staff.
12) Provide continuous thought partnership to regulatory staff for strategic problem solving.
13) Participate in performance evaluations.
14) Participate in hiring new staff.
1) Interpersonal skills., including being a team player.
2) Critical thinking and strategic problem-solving.
3) Oral and written communication.
4) Project management and organization.
5) Good Clinical Practice (GCP) standards.
1) Investigator-sponsored IND and/or IDE development and study management experience
2) Experience with one of the following: direct people management, employee training and /or employee development.
2) Cover letter
Note: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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